Retrospective Collection of Safety and Performance Data

Bone Defects Clinical Trial

Official title:

Retrospective Collection of Safety and Performance Data

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04644536
• Other study ID #: 2020.09
• Status: Recruiting
• Start date: November 25, 2020
• Est. completion date: December 2023

Study information

• Verified date: January 2022
• Source: Bioceramed
• Contact: A.C. Manjua
• Phone: 00351 210 966 988
• Email: clinicalresearch[@]bioceramed.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a retrospective post market clinical follow-up study to compile real world clinical data on safety and efficacy of the synthetic bone graft substitutes in a commercial clinical setting in long bone and extremity defects and in spinal fusion procedures.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients treated with Bioceramed bone substitutes at the Center.

• Long bone & extremities: bone grafting after post-traumatic or surgically created bone defects.

• Spine: degenerative disc disease or trauma who require spinal fusion of 1 or more vertebral bodies.

Exclusion Criteria:

Serious infection within two months before surgery, active malignancy, cellulitis, osteomyelitis, diseases interfering with bone metabolism (primary hyperparathyroidism, severe renal or hepatic insufficiency, non-treated hyperthyroidism), other bone metabolic diseases (osteomalacia, Paget disease, osteogenesis imperfecta), bone metastasis, primary bone tumors.

Related Conditions & MeSH terms

• Bone Defects

Intervention

Device:
• Bone graft substitute
Orthopaedic or Spine bony defects

Locations

Country	Name	City	State
Portugal	Hospital Lusíadas Lisboa	Lisboa

Sponsors (1)

Lead Sponsor	Collaborator
Bioceramed

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone healing, observable by x-ray/MRI	Primary endpoint will be successful radiographic bone repair.	6 months
Primary	Bone healing, observable by x-ray/MRI	Primary endpoint will be successful radiographic bone repair.	12 months
Secondary	Number and description of any adverse event during the follow-up	Record and description of any adverse event during the follow-up that reflects the safety of the bone graft substitute.	6 - 12 months